Job Title:
Director, CMC Modeling & Advanced Statistics
Location:
United States – Remote
(Additional Locations: Puerto Rico – Juncos; Massachusetts – Cambridge)
Job ID:
R-228785
Category:
Quality
Work Location Type:
Remote
Date Posted:
October 29, 2025
Salary Range (USD):
$207,002 – $238,637 (Annual)
About Amgen
At Amgen, our mission is to serve patients living with serious illnesses through scientific innovation. Since 1980, we have pioneered biotechnology advancements across Oncology, Inflammation, General Medicine, and Rare Diseases, reaching millions worldwide.
Our collaborative, science-driven culture empowers professionals to create meaningful impact while building dynamic, long-term careers. Join us and be part of a team transforming patient lives through breakthrough science.
Position Summary
The Director, CMC Modeling & Advanced Statistics will lead Amgen’s strategy in advanced statistical modeling to support Chemistry, Manufacturing, and Controls (CMC) development and commercial operations.
Reporting to the Senior Director, CMC Statistics, this role drives innovation in kinetic modeling, Bayesian statistics, and predictive analytics—enhancing decision-making, regulatory confidence, and process optimization across Amgen’s product portfolio.
Key Responsibilities
Strategic & Technical Leadership
Provide strategic direction and technical expertise in statistical modeling for CMC data across drug substance, drug product, and device development.
Lead development of Bayesian and kinetic models to support process characterization, specification setting, and stability modeling.
Integrate predictive modeling and machine learning approaches to enhance data-driven decision-making.
Champion digital and data science innovation through AI, automation, and simulation integration into statistical workflows.
Cross-functional Collaboration
Partner with Process Development, Analytical Sciences, Quality, Manufacturing, and Regulatory Affairs to ensure alignment of modeling strategies with scientific and business objectives.
Contribute to regulatory submissions by developing and defending modeling-based justifications in interactions with health authorities.
Represent Amgen externally via scientific collaborations, publications, and conferences to position the company as a thought leader in CMC modeling.
Leadership & Mentorship
Lead and mentor statisticians and data scientists, promoting the application of innovative statistical methods across teams.
Build organizational capability in Bayesian, kinetic, and predictive modeling techniques.
Qualifications
Basic Qualifications
Doctorate degree and 4+ years of relevant biopharmaceutical industry experience
OR
Master’s degree and 8+ years of relevant biopharmaceutical industry experience
OR
Bachelor’s degree and 10+ years of relevant biopharmaceutical industry experience
Additionally:
Minimum 4 years of people management or leadership experience (teams, projects, or programs).
Preferred Qualifications
Advanced degree in Statistics, Biostatistics, Applied Mathematics, Engineering, or related quantitative field.
Deep expertise in Bayesian methods, kinetic modeling, and advanced statistical frameworks.
Proven record applying statistical models to CMC data for process characterization, comparability, and analytical method development.
Proficiency with tools such as R, SAS, JMP, Minitab, MATLAB, NONMEM, Stan, or other modeling software.
Experience influencing regulatory strategy through model-based approaches.
Demonstrated ability to develop and lead technical talent.
Excellent communication skills for diverse audiences.
Proven success in cross-functional and global collaborations.
Core Competencies
Strategic statistical leadership and innovation
Technical mastery in modeling and Bayesian analysis
Regulatory awareness and scientific rigor
Strong analytical, communication, and decision-making skills
Team leadership, mentorship, and collaboration
Passion for data science and continuous improvement
What Amgen Offers
Amgen provides a Total Rewards Plan designed for personal and professional well-being, including:
Comprehensive benefits package:
Medical, dental, and vision coverage
Life and disability insurance
Flexible spending accounts
Retirement and Savings Plan with generous company contributions
Stock-based long-term incentives and annual performance bonus
Award-winning time-off policies
Flexible work models (remote/hybrid, where possible)
Career development programs, mentorship, and continuous learning opportunities
Equal Opportunity Statement
Amgen is an Equal Opportunity Employer committed to building a diverse and inclusive workplace. All qualified applicants will receive consideration without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran status, or disability.
Amgen provides reasonable accommodations for individuals with disabilities throughout the hiring and employment process.
How to Apply
Apply via careers.amgen.com.
Applications remain open until the position is filled.
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